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The Life Sensor Cardiac Monitor (CM) is a wireless monitoring system intended for use by healthcare professionals for monitoring of physiological data within healthcare settings. This includes heart rate and electrocardiography (ECG). Data is transmitted wirelessly from Life Sensor Electrode to an application on iOS device where it is displayed for review by healthcare professionals. The device is intended for use on general care patients 18 years or older and by prescription only. The device is contraindicated for use on critical care patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD), and left ventricular assist devices (LVAD); for use in magnetic resonance (MR) environments; for use during surgical procedures when electro-surgical equipment is optional. The Life Sensor Cardiac Monitor does not detect or diagnose medical conditions.

The Life Sensor Cardiac Monitor (CM) Platform is a wireless data collection system that monitors physiological data (electrocardiograph and heart rate) and consists of the following sub-systems: Life Sensor Electrode (includes Life Sensor Patch and Life Sensor Module) Life Sensor Firmware Life Sensor Application Life Sensor Electrode - Life Sensor Patch: The Life Sensor Patch is the single-use, self-adhesive interface to a patient that is attached to the patient's upper torso region just above the heart. - . Life Sensor Module: The Life Sensor Module attached to the Life Sensor Patch, contains the battery powered electronics and sensing apparatus necessary to operate the system. The Life Sensor Module automatically performs all the processing functions related to capturing the required physiological data from the body and performs encrypted, bi-directional communication to the Life Sensor Application, using Bluetooth Low Energy (BLE), when in range of the Life Sensor Application installed on a paired iOS device. - Life Sensor Firmware: The Life Sensor Firmware is the software installed on the Life Sensor Module. The Life Sensor Firmware manages bi-directional communication between the Life Sensor Module and the Life Sensor Application. Encrypted data is transmitted to and from the Life Sensor Module and the Life Sensor Application. - . Life Sensor Application: The Life Sensor Application, installed on a paired iOS device, interacts with the Life Sensor Firmware and manages the upload, processing, and display of the physiological data transmitted by the Life Sensor Module. When installed on a compatible hardware, the Life Sensor Application establishes connection to any of the Life Sensor Electrode through pairing process. Life Sensor Application has visual alarms to alert clinical personnel when heart rate of the person being monitored is outside the set limits, lead off, asystole, tachycardia and bradycardia, when the battery is low, or when there is loss of communication between the Life Sensor Application and the Life Sensor Electrode.